FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1001507
·
Received February 20, 2008
Report
- Report Number
- 9616099-2008-00412
- Event Type
- Injury
- Date Received
- February 20, 2008
- Date of Event
- October 6, 2007
- Report Date
- January 29, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORTS #: 9616099-2008-00412 AND 9616099-2008-00413. IN ADDITION A PREVIOUS ADVERSE EVENT INVOLVING THESE SAME DEVICES WAS REPORTED UNDER MANUFACTURING REPORT NUMBER 9610978-2004-00307. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED FROM THE CLINICAL STUDY INDICATES THAT THE PATIENT WAS HOSPITALIZED FOR A MYOCARDIAL INFARCTION AND PERCUTANEOUS CORONARY INTERVENTION. THE INITIAL REPORTER OF THIS EVENT HAS INDICATED THAT THERE IS NO ADDITIONAL INFORMATION AVAILABLE FOR THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS DE MEXICO | NA | I0104021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| L| R |